Either you have JavaScript disabled or your browser does not support Javascript . To work properly, this page requires JavaScript to be enabled.
How to enable JavaScript in your browser?

A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis

Next Previous
X
Search
Trial Profile

A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 06 Feb 2025

Price :

$35 *

Note:
  • Adis is an information provider.
  • Final gross price and currency may vary according to local VAT and billing address.
  • Your purchase entitles you to full access to the information contained in our trial profile at the time of purchase.
  • A link to download a PDF version of the trial profile will be included in your email receipt.

At a glance

  • Drugs Ustekinumab (Primary) ; Ustekinumab (Primary)
  • Indications Ulcerative colitis
  • Focus Registrational; Therapeutic Use
  • Acronyms UNIFI
  • Sponsors Janssen Research & Development; Janssen-Cilag

    • Most Recent Events

    • 17 Oct 2023 Results of matching-adjusted indirect comparisons (MAIC) of the efficacy and safety of Upadacitinib vs Vedolizumab, Ustekinumab and Tofacitinib in the phase 3 maintenance studies U-ACHIEVE, GEMINI-1, UNIFI & OCTAVE Sustain, presented at the 31st United European Gastroenterology Week.
    • 09 May 2023 Results (placebo (n=145 subjects), UST 130 mg (n=155 subjects)) assessing the underlying molecular mechanism of action of ustekinumab in ulcerative colitis, presented at the Digestive Disease Week 2023.
    • 09 May 2023 Pooled data from U-ACHIEVE (NCT02819635) and U-ACCOMPLISH (NCT03653026) and UNIFI (NCT02407236) studies evaluating the comparison of efficacy and safety of Upadacitinib versus Ustekinumab as induction therapy, presented at the Digestive Disease Week 2023.

You need to be a logged in or subscribed to view this content Request demo

If your organization or you do not have a subscription, try one of the following:
  • Contacting your organization’s admin about adding this content to your AdisInsight subscription
  • Buying a PDF version of any individual profile
  • Request a free trial
If your organization has a subscription, there are several access options, even while working remotely:
  • Working within your organization’s network
  • with username/password or try to via your institution
  • Persisted access using your organization’s identifier stored in your user browser for 90 days
Back to top